Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects

Overweight Clinical Trial

— ROQ_NUTRIMETAB  

Official title:

Study of the Consumption of Nutriose on Satiety, Weight Loss and Fat Mass Reducing in Overweight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897662
• Other study ID #: ROQ_NUTRIMETAB10
• Secondary ID: 2011-A00062-39
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2013
• Last updated: July 11, 2013
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Nealth Sarl
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." Recent work in China in overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the possible mechanisms of action, are the metabolites produced by colonic fermentation of NUTRIOSE.

The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on satiety and satiation and changes in colonic flora and its metabolites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy people

• aged between 20 and 50 years

• BMI between 27 and 29 kg/m2

• without metabolic syndrome

• no pregnant nor nursing women

• covered by Social Security

• negative serology for hepatitis B/C and HIV

• who signed the informed consent form

Exclusion Criteria:

• persons abusing drugs (laxatives, anti-diarrheal, agents acting on satiety)

• person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study

• person intolerant to gluten and / or allergic to wheat flour

• person in diet during the last 3 months

• person in vegetarian or vegan diet

• person who donated blood during the 3 months preceding the study

• Inclusion in another clinical study

• subjects receiving over 4,500 Euros in the last 12 months (including the present study)

• subjects presenting risk of non-compliance in the opinion of the recruiting doctor.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• NUTRIOSE FB06
14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day
• GLUCIIDEX 21
7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day

Locations

Country	Name	City	State
France	CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier	Bondy	Seine-Saint-Denis

Sponsors (2)

Lead Sponsor	Collaborator
Nealth Sarl	Roquette Freres

Country where clinical trial is conducted

France, 

References & Publications (6)

Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE® dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men. Int J Food Sci Nutr. 2011 Sep;62(6):628-35. doi: 10.3109/09637486.2011.569492. Epub 2011 May 19. — View Citation

Haarman M, Knol J. Quantitative real-time PCR assays to identify and quantify fecal Bifidobacterium species in infants receiving a prebiotic infant formula. Appl Environ Microbiol. 2005 May;71(5):2318-24. — View Citation

Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074. — View Citation

Ruskoné-Fourmestraux A, Attar A, Chassard D, Coffin B, Bornet F, Bouhnik Y. A digestive tolerance study of maltitol after occasional and regular consumption in healthy humans. Eur J Clin Nutr. 2003 Jan;57(1):26-30. — View Citation

Slavin JL, Savarino V, Paredes-Diaz A, Fotopoulos G. A review of the role of soluble fiber in health with specific reference to wheat dextrin. J Int Med Res. 2009 Jan-Feb;37(1):1-17. Review. — View Citation

Suzuki K, Simpson KA, Minnion JS, Shillito JC, Bloom SR. The role of gut hormones and the hypothalamus in appetite regulation. Endocr J. 2010;57(5):359-72. Epub 2010 Apr 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight		D-7; D28; D56; D84	No
Secondary	satiety		D-7; D28; D56; D84	No
Secondary	energy intake		D-7; D28; D56; D84	No
Secondary	BMI	Body Mass Index	D-7; D28; D56; D84	No
Secondary	body fat	measured by DEXA	D-7; D28; D56; D84	No
Secondary	waist size		D-7; D28; D56; D84	No
Secondary	glycemia		D-7; D28; D56; D84	No
Secondary	insulinemia		D-7; D28; D56; D84	No
Secondary	total cholesterol		D-7; D28; D56; D84	No
Secondary	LDL cholesterol		D-7; D28; D56; D84	No
Secondary	HDL cholesterol		D-7; D28; D56; D84	No
Secondary	triglyceridemia		D-7; D28; D56; D84	No
Secondary	HOMA	homeostasis model assessment (appreciates peripheral insulinoresistance and deficit in insulin secretion)	D-7; D28; D56; D84	No
Secondary	microbiota	measured by RT-PCR	D-7; D28; D56; D84	No
Secondary	blood pressure		D-7; D28; D56; D84	No
Secondary	digestive tolerance	measured with daily questionnaires	D-7; D28; D56; D84	No